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01-04-2016 | Neurology and Preclinical Neurological Studies - Original Article

The PROMESA-protocol: progression rate of multiple system atrophy under EGCG supplementation as anti-aggregation-approach

Authors: Johannes Levin, Sylvia Maaß, Madeleine Schuberth, Gesine Respondek, Friedemann Paul, Ullrich Mansmann, Wolfgang H. Oertel, Stefan Lorenzl, Florian Krismer, Klaus Seppi, Werner Poewe, Gregor Wenning, Armin Giese, Kai Bötzel, Günter Höglinger, The PROMESA study group

Published in: Journal of Neural Transmission | Issue 4/2016

Abstract

Formation of toxic α-synuclein oligomers appears to be a key underlying pathological mechanism of synucleinopathies such as Parkinson’s disease or multiple system atrophy (MSA). Given that Epigallocatechin-gallate has been shown to inhibit α-synuclein aggregation, it might represent a causal treatment option. Therefore, we set out to evaluate the safety, tolerability and a potential disease-modifying effect of Epigallocatechin-gallate in patients with MSA after 48 weeks of treatment. Power calculation was performed on existing natural history data on the progression of the Unified MSA Rating Scale as primary readout parameter. To assess the efficacy of Epigallocatechin-gallate versus placebo regarding the reduction of disease progression measured during the study period (80 % power, 5 % p level, 50 % effect size) 36 patients per group are needed. Considering a drop-out rate of 20 % a total of 86 patients will be recruited in this multicentre study. These data provide a solid rationale to investigate whether supplementation of Epigallocatechin-gallate can delay the progression of the MSA-related disability.

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Title: The PROMESA-protocol: progression rate of multiple system atrophy under EGCG supplementation as anti-aggregation-approach
Authors: Johannes Levin
Sylvia Maaß
Madeleine Schuberth
Gesine Respondek
Friedemann Paul
Ullrich Mansmann
Wolfgang H. Oertel
Stefan Lorenzl
Florian Krismer
Klaus Seppi
Werner Poewe
Gregor Wenning
Armin Giese
Kai Bötzel
Günter Höglinger
The PROMESA study group
Publication date: 01-04-2016
Publisher: Springer Vienna
Published in: Journal of Neural Transmission / Issue 4/2016
Print ISSN: 0300-9564
Electronic ISSN: 1435-1463
DOI: https://doi.org/10.1007/s00702-016-1507-8

At a glance: The STEP trials

Springer Medicine

The PROMESA-protocol: progression rate of multiple system atrophy under EGCG supplementation as anti-aggregation-approach

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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